Intermittent pneumatic compression versus additional prophylaxis with enoxaparin for prevention of venous thromboembolism after laparoscopic surgery for gastric and colorectal malignancies: multicentre randomized clinical trial. Issue 5 (23rd July 2020)

• Record Type: Journal Article
• Authors: Kamachi, H; Homma, S; Kawamura, H; Yoshida, T; Ohno, Y; Ichikawa, N; Yokota, R; Funakoshi, T; Maeda, Y; Takahashi, N; Amano, T; Taketomi, A
• Is Part Of: BJS open. Volume 4:Issue 5(2020)
• Page Start: 804
• Page End: 810
• Publication Date: 2020-07-23
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1002/bjs5.50323
• Languages: English
• ISSNs: 2474-9842

Abstract

Abstract: Background: The role of antithrombotic chemoprophylaxis in prevention of venous thromboembolism (VTE) in laparoscopic surgery for gastric and colorectal malignancies is unknown. This study compared the addition of enoxaparin following intermittent pneumatic compression (IPC) with IPC alone in patients undergoing laparoscopic surgery for gastrointestinal malignancy. Methods: In this multicentre RCT, eligible patients were older than 40 years and had a WHO performance status of 0 or 1. Exclusion criteria were prescription of antiplatelet or anticoagulant drugs and history of VTE. Patients were allocated to IPC or to ICP with enoxaparin in a 1 : 1 ratio. Stratification factors included sex, location of cancer, age 61 years and over, and institution. Enoxaparin was administered on days 1–7 after surgery. Primary outcome was VTE, evaluated by multidetector CT on day 7. Results: Of 448 patients randomized, 208 in the IPC group and 182 in the IPC with enoxaparin group were evaluated. VTE occurred in ten patients (4·8 per cent) in the IPC group and six (3·3 per cent) in the IPC with enoxaparin group ( P = 0·453). Proximal deep vein thrombosis and/or pulmonary embolism occurred in seven patients (3·4 per cent) in the IPC group and one patient (0·5 per cent) in the IPC with enoxaparin group ( P = 0·050). All VTE events were asymptomatic and non-fatal. Bleeding occurred in 11 of 202 patients in the IPC with enoxaparin group, and one patient needed a transfusion. All bleeding events were managed by discontinuation of the drug. Conclusion: IPC with enoxaparin after laparoscopic surgery for gastric and colorectal malignancies did not reduce the rate of VTE. Registration number: UMIN000011667 (https://www.umin.ac.jp/ ). Graphical Abstract: This RCT compared intermittent pneumatic compression (IPC) alone with IPC plus enoxaparin for 1 week after surgery in the prevention of venous thromboembolism (VTE) in patients undergoing laparoscopic surgery for gastric or colorectal malignancy. Although VTE occurred in 4·8 per cent of the ICP-alone group and 3·3 per cent of the ICP with enoxaparin group ( P = 0·453), the occurrence of proximal deep vein thrombosis and/or pulmonary embolism was reduced from 3·4 to 0·5 per cent by the addition of enoxaparin ( P = 0·050). No additional value of enoxaparin in patients who recover uneventful